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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04160013
Other study ID # 171485
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2017
Est. completion date January 19, 2019

Study information

Verified date November 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors.


Description:

A public health problem that needs to be solved is how to educate more parents about healthy discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by integrating evidence-based parent training into pediatric primary care. Some of the most modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The investigators define unhealthy parenting behaviors such as spanking, threatening, yelling, and humiliation. For adults in the original ACEs study, it was exposure to these behaviors that led to the categorization of child abuse/neglect and that were associated with heart disease, obesity, depression, smoking, drug use, violence, and many other problems. This study may help change policy and practice related to mitigating ACEs in primary care. To accomplish this goal, randomized controlled trials are needed to test brief screening tools and evidence-based resources. A population-based approach is needed to reach all parents (i.e. primary prevention). In the study, parents in the intervention group will receive 3 minutes of education about healthy discipline strategies.


Recruitment information / eligibility

Status Completed
Enrollment 533
Est. completion date January 19, 2019
Est. primary completion date November 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 2 Years
Eligibility Inclusion Criteria: - Parents of 6 month to 2 year old children presenting to the Vanderbilt Pediatric Primary Care Clinic for a well visit or an acute care visit. Exclusion Criteria: - Parents who do not speak and read English, Spanish, or Arabic. The interventions are only available in English, Spanish, and Arabic.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Discipline education
Discipline education using the Play Nicely program.
Cavity Prevention
Cavity prevention using a 2 page handout.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attitudes toward spanking A 10 item scale that assesses parents' attitudes about corporal punishment. The minimum value is 10 and the maximum value is 70. Higher scores indicate a higher likelihood of using spanking. 3-6 months post-enrollment.
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